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A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia

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Trial Profile

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Essential Thrombocythemia

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Jun 2026

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary)
  • Indications Essential thrombocythaemia
  • Focus Therapeutic Use
  • Acronyms EXCEED-ET
  • Sponsors PharmaEssentia Corporation

Most Recent Events

  • 22 May 2026 According to a PharmaEssentia Corporation media release, the data from the trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) 2026 Congress.
  • 13 Jan 2026 According to a PharmaEssentia Corporation media release, the USFDA has completed it's filing review of the company's BLA and did not identify any issues. This submission is sufficient to proceed with a substantive review for ropeginterferon alfa-2b-njft for the treatment of adult patients with ET. A PDUFA Date of August 30, 2026 has been given. This sBLA is supported by confirmatory evidence from the North American Phase 2b EXCEED-ET trial and results from the global Phase 3 SURPASS-ET trial
  • 12 Jan 2026 Results presented in the PharmaEssentia Media Release.

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